Multivalent PCV2 immunogenic compositions and methods of producing such compositions

Abstract

An improved method for recovering the protein expressed by open reading frame 2 from porcine circovirus type 2 is provided. Also provided is recombinant PCV2ORF2 protein, and immunogenic compositions comprising PCV2ORF2 protein. Moreover, multivalent combination vaccines are provided which include an immunological agent effective for reducing the incidence of or lessening the severity of PCV2 infection, preferably PCV2ORF2 protein, or an immunogenic composition comprising PCV2ORF2 protein, and at least one immunogenic active component of another disease-causing organism in swine.

We claim: 
     
       1. A single dose multivalent combination vaccine comprising:
 4 μg to 400 μg of recombinant PCV2 ORF2 protein per dose; 
 at least one pharmaceutically acceptable carrier selected from the group consisting of: effective amount of antimicrobial active agent, or an effective amount of a stabilizing agent that increases the shelf-life of the vaccine; 
 and at least one immunogenic active component against  Mycoplasma hyopneumoniae , Porcine Reproductive and Respiratory Syndrome Virus (PRRSV), or a combination thereof, 
 wherein said vaccine provides protective immunity and is effective for lessening the severity of against one or more clinical symptoms associated with PCV2 infection after the administration of a single dose of said vaccine, compared to those swine not receiving said vaccine and wherein said one or more clinical symptoms are selected from the group consisting of wasting, paleness of the skin, unthriftiness, respiratory distress, diarrhea, icterus, jaundice, lung lesions, nasal shedding, cough, diarrhea and combinations thereof, wherein said recombinant PCV2 ORF2 protein is selected from the group consisting of: 
 i) a polypeptide selected from the group consisting of SEQ ID NO: 5, SEQ ID NO: 6, and SEQ ID NO: 11; 
 ii) a PCV2 ORF2 polypeptide that is at least 90% identical to any polypeptide of i); or 
 iii) a polypeptide that is encoded by a DNA comprising the sequence of SEQ ID NO: 3 or SEQ ID NO: 4. 
 
     
     
       2. The single dose multivalent combination vaccine of  claim 1 , wherein said vaccine comprises recombinant PCV2 ORF2 protein further comprises an additional component selected from the group consisting of an inactivated viral vector, cell culture supernate, BEI, sodium thiosulfate, carriers, adjuvants, media, viral inactivators, diluents, isotonic agents, immunomodulatory agents, antibiotics, pharmaceutical acceptable salts, and combinations thereof. 
     
     
       3. The single dose multivalent combination vaccine of  claim 1 , wherein one dose of said single dose vaccine has a volume of at least 1 ml. 
     
     
       4. The single dose multivalent combination vaccine of  claim 1 , wherein one dose of said vaccine has a volume of 2 ml. 
     
     
       5. The single dose multivalent combination vaccine of  claim 1 , wherein said vaccine is retained within a container. 
     
     
       6. The single dose multivalent combination vaccine of claim  1 , wherein said further immunogenic active component is  Mycoplasma hyopneumoniae.    
     
     
       7. The single dose multivalent combination vaccine of  claim 1 , wherein said further immunogenic active component is PRRSV. 
     
     
       8. The single dose multivalent combination vaccine of  claim 1 , wherein said further immunogenic active components are  Mycoplasma hyopneumoniae  and PRRSV. 
     
     
       9. The single dose multivalent combination vaccine of  claim 7 , wherein said vaccine comprises 3-10 logs of PRRSV. 
     
     
       10. The single dose multivalent combination vaccine of  claim 7 , wherein said vaccine additionally comprises a PRRSV antigen. 
     
     
       11. The single dose multivalent combination vaccine of  claim 1 , wherein the amount of PCV2 ORF2 protein in said vaccine is 4 μg to 200 μg per dose.